The title of Acetive Therapeutics Inc. (NASDAQ:AQST) was trading lower on Friday, with session volume rising to 5.68 million compared to its average volume of 2.79 million, according to data from Benzinga Pro.
Why did he fall?
On Friday, the company said the U.S. Food and Drug Administration (FDA) has identified deficiencies in Anaphylm‘s new drug application (NDA) that prevent any discussion of labeling and post-market commitments at this time.
Although the notification did not specify the deficiencies, Aquestive is working to understand and resolve the issues. The FDA said the notification does not reflect a final decision on the pending application, and the FDA’s review continues.
Anaphylm (dibutepinephrine) is a polymer matrix-based prodrug drug candidate. The company is seeking approval of the drug for the treatment of severe allergic reactions, including anaphylaxis.
Anaphylm is the size of a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is necessary for its administration.
Aquestive Therapeutics is advancing the global expansion of Anaphylm with plans to submit applications for regulatory approval in Canada, Europe and the United Kingdom in 2026.
And after?
The company is in contact with the FDA to gather further information on the deficiencies identified, with the aim of correcting them before the PDUFA action date of January 31, 2026.
The FDA said the review is still ongoing and clarified that no disciplinary review letters will be issued, although requests for information are possible during the remaining review period.
However, a further delay in communicating specific deficiencies could result in a delay in the potential approval of Anaphylm.
Aquestive ended 2025 with approximately $120 million in cash and cash equivalents. The Company continues to believe this funding is sufficient to complete the approval and launch processes for Anaphylm in the United States, if the drug gains FDA approval, while also advancing Anaphylm in other key markets outside the United States.
In September 2025, ARS Pharmaceuticals Inc. (NASDAQ:SPRY) filed a petition asking the FDA to delay approval of Aquestive’s investigational epinephrine treatment, citing concerns related to safety, dosing and real-life use.
The AQST price movement: Aquestive Therapeutics’ stock was down 40.18% to $3.71 at press time Friday, according to data from Benzinga Pro.
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